Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (Final Report)

Notice

EPA is releasing a final report describing the evaluation and applications of physiologically based pharmacokinetic (PBPK) models in health risk assessment. This was announced in the September 22 2006 Federal Register Notice.

Abstract

This final report, Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment addresses the application and evaluation of PBPK models for risk assessment purposes. These models represent an important class of dosimetry models that are useful for predicting internal dose at target organs for risk assessment applications.

The purpose of this final report is to serve as a learning tool for EPA scientists and risk assessors, as well as highlight the benefits of using PBPK modeling. The report can also be informative to PBPK modelers within and outside the Agency, as it describes the types of data and models that the EPA requires for consideration of a model for use in risk assessment. The report gives an overview of PBPK modeling and the data needed to develop these models, as well as provides considerations for evaluating these models prior to using them to perform interspecies, intraspecies, and other extrapolations needed in risk assessment. In addition, the appendix compiles a list or relevant publications current as of the end of 2005. The report does not issue Agency guidance on the use of PBPK modeling and does not specify when to use a PBPK model in risk assessment.

Status

This is the final report. Portions of this report may be published in peer-review literature.

History/Chronology

EPA award releases a solicitation for a contract to develop a report for the Application of Physiologically Based Pharmacokinetic Data and Models in Risk Assessment.

2004

A Draft document is released for internal review.

Jul 2005

EPA released an external review draft report for public comment.

Nov 2005

A draft of this report was subjected to an external review by a panel of independent experts.

Aug 2006

EPA released the final report.

This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names
or commercial products does not constitute endorsement or recommendation for use.